Stem Cell Therapy for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneration Biomedical, Inc.

Must be taking: Donepezil, Memantine, AChEIs

Must not be taking: Other AD medications

Disqualifiers: Neurological, Psychiatric, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stem cell therapy, using cells from a participant's own fat tissue, can safely treat Alzheimer's disease. The study will test different doses to ensure safety. It seeks individuals with mild to moderate Alzheimer's who are generally in good health. Participants should not have other neurological disorders or a history of cancer in the past five years. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications if they are stable for at least 3 months and do not include other Alzheimer's medications, except for donepezil, memantine, AChEIs, Vitamin E, fish oil, and gingko biloba.

Do I have to stop taking my current medications for the trial?

The trial allows certain Alzheimer's medications like donepezil, memantine, and some supplements if you've been on a stable dose for at least 3 months. Other Alzheimer's medications are not allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that stem cells taken from fat tissue are safe for people. Early studies that injected these cells into the brain revealed no major safety issues or harmful effects. This suggests the treatment could be safe for humans. However, as this trial is in an early stage, it aims to further confirm the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard treatments for Alzheimer's, which often include medications like cholinesterase inhibitors and memantine, RB-ADSC therapy is derived from stem cells. Researchers are excited about these treatments because they use regenerative stem cells, specifically adipose-derived stem cells (ADSCs), which have the potential to repair and regenerate damaged brain tissues. Additionally, this therapy is directly infused into the brain via an Ommaya reservoir, a novel delivery method that could enhance the treatment's effectiveness by targeting the affected areas more precisely. The different dosing arms—low, medium, and high—allow researchers to explore the optimal dosage for maximizing benefits while minimizing risks.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research has shown that RB-ADSC, a treatment using stem cells from a person's own fat, may help with Alzheimer's disease. These stem cells activate to produce Wnt, a protein that aids in cell growth and repair. Early results from other studies suggest that the treatment is safe when injected into the brain. While direct evidence of its effectiveness for Alzheimer's is still being gathered, this method leverages the body's natural repair abilities, which might aid in repairing brain cells in Alzheimer's patients. Participants in this trial will receive different doses of RB-ADSC to evaluate its safety and potential benefits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-80 with mild to moderate Alzheimer's Disease, who can donate their own fat tissue for treatment and have a caregiver. Participants should be in good health, with stable medications for other conditions, and no recent cancer or stem cell treatments.

Inclusion Criteria

My thinking and memory skills are good.

My other health conditions are stable and I've been on the same medication for 3 months.

I have been diagnosed with mild to moderate Alzheimer's disease.

Exclusion Criteria

I have a neurological condition, but it's not Alzheimer's disease.

I have not had any stem cell implantation in the last 3 months.

I have had cancer within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intracerebroventricular injections of ex vivo expanded, autologous adipose-derived stem cells (ADSCs) through an Ommaya reservoir

28 weeks

Regular visits for monitoring adverse events and dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up visits for clinical assessments and imaging

What Are the Treatments Tested in This Trial?

Interventions

• RB-ADSC

Trial Overview The study tests the safety of RB-ADSC, a new therapy using participants' own fat-derived cells to treat Alzheimer's. It aims to see if this approach is safe and how it affects the disease symptoms.

How Is the Trial Designed?

Group I: RB-ADSC medium dose Experimental Treatment 1 Intervention

Participants will receive one dose of 5x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Group II: RB-ADSC low dose Experimental Treatment 1 Intervention

Participants will receive one dose of 2x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Group III: RB-ADSC high dose Experimental Treatment 1 Intervention

Participants will receive one dose of 10x10\^6 RB-ADSC infused in the previously implanted Ommaya reservoir

Who Is Running the Clinical Trial?

Regeneration Biomedical, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Adipose-derived stem cells (ASCs) show promise as a potential treatment for Alzheimer's disease (AD), demonstrating significant improvements in memory and neuropathology in Tg2576 mice, a model for AD.

The study indicates that both intravenous and intracerebral transplantation of human ASCs can effectively enhance cognitive function, highlighting their therapeutic potential for neuroregeneration in AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic effects of human adipose-derived stem cells in Alzheimer's disease mouse models. Chang, KA., Kim, HJ., Joo, Y., et al.[2018]

Adipose tissue-derived stromal cells (ADSCs) can be isolated from adult human fat and have the potential to differentiate into neuron-like cells, indicating they could serve as a new source for cell transplantation in the central nervous system.

While only 0.1%-0.2% of ADSCs differentiated into neuron-like cells, these cells exhibited key neuronal characteristics, suggesting that ADSCs could be a viable autologous stem cell source for neurological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The in vitro study of the human adipose tissue-derived stromal cells differentiating into the neuron-like cells]. Yang, L., Zheng, J., Wang, C.[2014]

Adipose tissue-derived stromal cells (ADSCs) successfully expressed the LacZ gene after being transplanted into the brains of adult rats, indicating their potential for gene therapy applications.

The transplanted ADSCs integrated well into the host brain tissue without causing disruption, overproliferation, or gliosis, suggesting they are safe and compatible for use in treating central nervous system disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells as vector for gene therapy in central nervous system]. Yang, LY., Zheng, JK., Hui, GZ., et al.[2012]

Adipose tissue-derived stromal cells from adult rats can be successfully induced to differentiate into neuron-like cells using beta-mercaptoethanol, demonstrating their potential as a source for central nervous system transplantation.

With an optimal differentiation protocol, 60%-85% of these cells expressed neuron-specific markers, indicating they can effectively take on a neuronal phenotype, which supports their use in regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adipose tissue-derived stromal cells differentiate into neuron-like cells]. Yang, L., Zheng, J., Liu, X., et al.[2006]

Cultured adipose tissue-derived stem cells (ADSC) can enhance the survival, migration, and tube formation of human endothelial cells by secreting important growth factors like VEGF and HGF, indicating their potential role in promoting blood vessel formation.

In a mouse model of ischemia, transplantation of ADSC improved blood flow and capillary density in the affected area after 4 weeks, suggesting that these cells could be an effective therapy for ischemic diseases, although they do not directly become endothelial cells themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel autologous cell therapy in ischemic limb disease through growth factor secretion by cultured adipose tissue-derived stromal cells. Nakagami, H., Maeda, K., Morishita, R., et al.[2022]

Adipose-derived stem cells (ADSCs) can be easily harvested from piglets' fat tissue and expanded in culture, maintaining their stem cell characteristics over more than 15 passages.

These ADSCs have the potential to differentiate into neuron-like cells, suggesting that adipose tissue could serve as a viable alternative source for stem cell therapy in treating nervous system injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuron-like differentiation of adipose-derived stem cells from infant piglets in vitro. Huang, T., He, D., Kleiner, G., et al.[2019]

Transplanting adipose-derived mesenchymal stem cells into the hippocampi of Alzheimer's model mice significantly increased the generation of new brain cells, indicating enhanced neurogenic activity.

This treatment not only reduced oxidative stress but also improved cognitive function in the mice, suggesting a potential therapeutic approach for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cell transplantation promotes adult neurogenesis in the brains of Alzheimer's disease mice. Yan, Y., Ma, T., Gong, K., et al.[2021]

Topical treatment with adipose-derived stem cells (ADSC) significantly improved corneal wound healing in injured rat corneas, showing smaller epithelial defects compared to control and adipose-treated eyes.

Histological analysis revealed that ADSC-treated corneas achieved complete re-epithelization with reduced inflammation and fibroblast activation, indicating a beneficial effect on corneal repair mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose-derived stem cells for the treatment of chemically burned rat cornea: preliminary results. Zeppieri, M., Salvetat, ML., Beltrami, AP., et al.[2013]

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05667649

Autologous Activated Adipose-derived Stem Cells (RB- ... This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible ...

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000210642

Intracerebroventricular Injection of Autologous Adipose- ... This “first-in-human” trial of intracerebroventricular injection of Wnt-expressing, adipose-derived stem cells proved well-tolerated and safe in this cohort.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07205601

NCT07205601 | Study of Intracerebroventricular Injections ... The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from ...

4. biospace.com biospace.com/press-releases/regeneration-biomedical-to-present-updated-phase-1-trial-data-on-autologous-stem-cell-therapy-injected-directly-into-the-brain-for-alzheimers-disease-in-podium-presentation-at-the-isct-2025-scientific-annual-meeting

Regeneration Biomedical to Present Updated Phase 1 ... RB-ADSCs are highly purified, Wnt-activated adipose-derived stem cells obtained from a patient's own adipose tissue. This first-in-class stem ...

5. cgtlive.com cgtlive.com/view/trial-regeneration-biomedical-alzheimer-disease-stem-cell-therapy-doses-first-patient

Trial for Regeneration Biomedical's Alzheimer Disease ... RB-ADSC consists of stem cells derived from patient's own adipose tissue via lipoaspirate that have been expanded ex vivo with selection for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1465324925000945

Interim Results of a "First-in-Human" Phase 1 Clinical ... We test the safety of using Wnt-activated adipose tissue-derived stem cells (ADSCs) injected directly into the ventricles of the brain to address multifactorial ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713646/

Intracerebroventricular injection of autologous, Wnt‐ ... This “first in human” trial of intracerebroventricular injection of Wnt‐expressing, adipose‐derived stem cells appears well‐tolerated and safe ...